OncoMatch/Clinical Trials/NCT05659628
CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL
Is NCT05659628 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD19-7×19 CAR-T combined with Tislelizumab for diffuse large b-cell lymphoma.
Treatment: CD19-7×19 CAR-T combined with Tislelizumab — The goal of this clinical trial is to test CD19-7×19 CAR-T cells combined with Tislelizumab in refractory and relapsed diffuse large B lymphoma. The main question\[s\] it aims to answer are: question 1：What is the safety of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma. question 2：What is the efficacy of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma. Participants will be asked to receive clinical evaluation before CAR-T, including physical examination, blood routine test, biochemical test, imaging test, etc.Peripheral blood lymphocytes will be collected for preparation of CAR-T cells after enrollment. Pretreatment chemotherapy with fludarabine and cyclophosphamide will be used before CAR-T infusion. On the 31st day after CAR-T infusion, Tislelizumab 200mg was given once every 21 days for 6 cycles. Participants will be required to report concomitant medication and adverse events, and their disease was evaluated throughout the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: CD20 monoclonal antibody (rituximab)
Previous treatment for patients with diffuse large B cell lymphoma must include rituximab (CD20 monoclonal antibody)
Must have received: anthracycline
Previous treatment for patients with diffuse large B cell lymphoma must include...anthracyclines
Cannot have received: CAR-T cell therapy
Exception: within 3 months before this CAR-T treatment
Any target CAR-T treatment was performed within 3 months before this CAR-T treatment
Cannot have received: PD-1 monoclonal antibody
Previously used any commercially available PD-1 monoclonal antibody
Cannot have received: autologous hematopoietic stem cell transplant
Exception: within 6 weeks
Autologous hematopoietic stem cell transplantation was performed within 6 weeks
Cannot have received: cytotoxic chemotherapy
Exception: within 2 weeks before cell collection
Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection
Cannot have received: glucocorticoid
Exception: within 2 weeks before cell collection
Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection
Cannot have received: targeted therapy
Exception: within 2 weeks before cell collection
Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection
Lab requirements
Blood counts
Absolute value of peripheral blood neutrophils ≥ 1000/μl. Platelets ≥ 45000/μl
Kidney function
creatinine < 1.5mg/dL
Liver function
ALT/AST < 2.5x ULN; Total bilirubin < 1.5mg/dL
Cardiac function
Cardiac ejection fraction (EF) ≥ 50%
creatinine < 1.5mg/dL; ALT/AST Less than 2.5 times of normal upper limit; Total bilirubin < 1.5mg/dL; Cardiac ejection fraction (EF) ≥ 50%; Absolute value of peripheral blood neutrophils ≥ 1000/μl. Platelets ≥ 45000/μl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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